Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

NARecruitingINTERVENTIONAL
Enrollment

286

Participants

Timeline

Start Date

October 24, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Opioid UseAuriculotherapyPain, AbdominalCancer PainLiver Transplant
Interventions
DEVICE

NSS-2 BRIDGE

"NBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.~Once the device is placed, subjects will be asked to perform a pinch test throughout the duration of their time wearing the device. To perform the pinch test subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose."

DEVICE

Sham NSS-2 BRIDGE

Sham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.

Trial Locations (4)

15213

RECRUITING

University of Pittsburgh Medical Center - Magee-Womens Hospital, Pittsburgh

RECRUITING

UPMC Montefiore Hospital, Pittsburgh

15232

RECRUITING

University of Pittsburgh Medical Center - Shadyside Hospital, Pittsburgh

15237

RECRUITING

University of Pittsburgh Medical Center - Passavant Hospital, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Masimo Corporation

INDUSTRY

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Jacques E. Chelly

OTHER